Package 25682-007-01
Brand: kanuma
Generic: sebelipase alfaPackage Facts
Identity
Package NDC
25682-007-01
Digits Only
2568200701
Product NDC
25682-007
Description
1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
kanuma
Generic
sebelipase alfa
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "341de317-904b-4933-88da-b239c5989871", "openfda": {"nui": ["N0000192342", "N0000192343", "M0004273"], "unii": ["K4YTU42T8G"], "rxcui": ["1726979", "1726984"], "spl_set_id": ["83a77b9d-42f0-4645-8420-786285da7326"], "pharm_class_cs": ["Sterol Esterase [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]", "Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]"], "manufacturer_name": ["Alexion Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS", "package_ndc": "25682-007-01", "marketing_start_date": "20151208"}], "brand_name": "KANUMA", "product_id": "25682-007_341de317-904b-4933-88da-b239c5989871", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]", "Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]", "Sterol Esterase [CS]"], "product_ndc": "25682-007", "generic_name": "Sebelipase alfa", "labeler_name": "Alexion Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KANUMA", "active_ingredients": [{"name": "SEBELIPASE ALFA", "strength": "2 mg/mL"}], "application_number": "BLA125561", "marketing_category": "BLA", "marketing_start_date": "20151208", "listing_expiration_date": "20261231"}